Kaneka Endovascular Embolization and Protection

N/AActive Not RecruitingNCT05563051

Kaneka Medical America LLC164 enrolled

Overview

Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s) Study Duration Anticipated timeline for study: Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Aneurysm Cerebral

Interventions

i-ED COILDEVICE

The i-ED COIL System (i-ED COIL and detachment box) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Target aneurysm of 4mm - 14mm in size * Ruptured or unruptured * Suitable for embolization with coils * May be treated with or without assist devices Exclusion Criteria: * Unstable neurological deficit in unruptured cases (condition worsening within last 90 days) * Pre-planned staged procedure of target aneurysm * mRS score 3 or more * Hunt Hess Score more than 3 for subjects with ruptured aneurysm * Evidence of active infection (e.g.,fever, temperature \>38 degrees C and/or WBC \>15,000)

Locations (4)

McLaren Health Care

Grand Blanc, Michigan, United States

Northwell Health Lenox Hill Hospital

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

SSM Health St. Anthony's Hospital

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Adequate Occlusion

Proportion of subjects who achieve Adequate Occlusion (Modified Raymond-Roy I or II Classification)

Time frame: 12 months

Secondary Outcomes

Complete Occlusion

Complete occlusion at 1 year (Modified Raymond-Roy I)

Time frame: 12 months

Packing Density

Aneurysm volume and percent of aneurysm packing for coil embolization. Packing density will be evaluated based on aneurysm volume and coil volume

Time frame: 12 months

Modified Rankin Score

Modified Rankin Score (Scale from 0-6), the lower the score the better - 0 No symptoms and 6 is dead. 1. No significant disability. Able to carry out all usual activities, despite some symptoms. 2. Slight disability. Able to look after own affairs without assistance but unable to carry out all previous activities. 3. Moderate disability. Requires some help, but able to walk unassisted. 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. Dead

Time frame: 12 months

Retreatment

Any retreatment of the aneurysm, surgically or interventional embolization

Time frame: 12 months

Adverse events

Device or procedure related adverse events

Time frame: 12 months

Data from ClinicalTrials.gov

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